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Multicenter, retrospective-prospective, real-world observational study, with the aim of evaluating tolerability and efficacy in a population of patients treated according to clinical practice outside of studies randomized.
Patients affected by will be included in the study and analyzed HER2 positive breast cancer with residual invasive disease after neoadjuvant chemotherapy, treated consecutively with adjuvant T-DM1 at the various Italian oncology centers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective cohort | 80 patients will form the retrospective cohort, considering consecutively all patients treated according to clinical practice outside of studies randomized |
| |
| Prospectively cohort | Additional 80 patients who meet the inclusion criteria will be enrolled prospectively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-DM1 adjuvant | Drug | Evaluate the tolerability of treatment with adjuvant T-DM1 after failure to respond complete pathology to neoadjuvant treatment in terms of adverse events |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the tolerability. | Evaluate the tolerability of the treatment in terms of adverse events, defined according to Common Terminology Criteria for Adverse Events (CTCAE, version 4), in a population of patients treated with adjuvant T-DM1 in "real life" | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of treatment. | Evaluate in the "real life setting" the effectiveness of adjuvant treatment in terms of survival free from disease (Disease Free Survival, DFS) in patients with HER2 positive breast cancer and residual invasive disease (on T and/or on N) after neoadjuvant chemotherapy. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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HER2 positive breast cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrizia Vici, Doctor | Contact | +39 06-5266.5698 | +39 | patrizia.vici@ifo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Regina Elena" National Cancer Institute | Recruiting | Rome | Rome | 00144 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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